Evaluation of the Integrated Radio Frequency Denervation System to Improve Glycemic Control in Type 2 Diabetic Subjects

NCT04285554 | Completed DMC FDA Device

• 1 other identifier: 932
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 8

Brief Summary

The objective of this early feasibility study is to evaluate the safety and performance of intravascular hepatic denervation using the Metavention Integrated Radio Frequency Denervation System (iRF System) to improve glycemic control in type 2 diabetes subjects.

Conditions

Diabetes Mellitus, Type 2

Keywords

Metabolic Syndrome; NAFLD; Hypertension; High Blood Pressure; Glycemic Control; Diabetes; Denervation; Sympathetic Nervous System

Outcome Measures

Primary Outcomes (1)

• Rate of Serious Adverse Device Effects

  The incidence rate of serious adverse device effects (SADEs) from time of Index Procedure through 90 days.

  Index Procedure through 90 days

Secondary Outcomes (7)

• Change in glycemic control: HbA1c

  30, 90, 180 and 365 days

• Change in glycemic control - FPG

  30, 90, 180 and 365 days

• Change in glycemic control - Insulin

  30, 90, 180 and 365 days

• Change in glycemic control - C-peptide

  30, 90, 180 and 365 days

• Change in office blood pressure

  30, 90, 180 and 365 days

Study Arms (1)

Hepatic Denervation

EXPERIMENTAL

Device: iRF System Hepatic Denervation

Interventions

iRF System Hepatic Denervation DEVICE

The iRF System is a percutaneous, catheter-based device which uses RF energy to circumferentially denervate the sympathetic nerves surrounding the common hepatic artery (CHA).

Hepatic Denervation

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥22 and ≤70 years old
• Type 2 diabetes diagnosis meeting the following criteria:
• HbA1c \> 7.0% and ≤ 9.0% (53 mmol/mol - 75 mmol/mol), AND
• On at least two anti-diabetic medications; one at the highest tolerated dose with no changes in medication dose in the 12 weeks prior to the first screening visit
• Waist circumference ≥102 cm (male) and ≥88cm (female)
• Diagnosis of hypertension: SBP ≥140mmHg OR SBP ≥130mmHg on hypertension medication(s)
• Documented status of stable lifestyle modifications
• Women of childbearing potential (WOCBP) must be using at least one acceptable method of contraception throughout the study

You may not qualify if:

• BMI \>40 kg/m2
• Diagnosis of type 1 diabetes
• Use of insulin within 90 days of consent
• Two or more self-reported or documented severe hypoglycemia events (severe hypoglycemia event defined as: hypoglycemia associated with severe cognitive impairment requiring external assistance for recovery) in the 180 days prior to Index Procedure
• One or more documented hyperglycemia episodes requiring hospitalization in the 180-days prior to Index Procedure
• During medication run in period, uncontrolled hyperglycemia noted by a fasting glucose value of \>270mg/dL or \>360mg/dL at any point that is then confirmed by a second measurement (not on the same day)
• A history of bariatric surgery, renal denervation, baroreflex activation therapy, or liver transplant, or these procedures are planned in the 365 days following Index Procedure
• Any surgical procedure within 30 days prior to Index Procedure
• History of or current symptomatic gallstones (e.g., cholecystitis, bile duct dilatation) without a cholecystectomy being performed (Note: subjects who have had a cholecystectomy are not excluded)
• Previous hepatobiliary surgery/intervention that in the opinion of the investigator could preclude the ability to perform denervation of the common hepatic artery
• Currently taking the following medications within 90 days prior to screening and/or there is a need or anticipated need for these medications during the study:
• Systemic corticosteroids
• Anticonvulsants
• Centrally acting sympatholytics
• Use of anticoagulation therapy which cannot be discontinued from 7 days before to 14 days after the Index Procedure

Sponsors & Collaborators

• Metavention: lead

Study Sites (8)

Cardiology, P.C.

Birmingham, Alabama, 35211, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

AdventHealth Translational Research Institute

Orlando, Florida, 32804, United States

Location

Prairie Education & Research Cooperative (PERC)

Springfield, Illinois, 62701, United States

Location

Metropolitan Cardiology Consultants

Coon Rapids, Minnesota, 55433, United States

Location

South Oklahoma Heart Research, LLC

Oklahoma City, Oklahoma, 73135, United States

Location

UPMC Pinnacle

Harrisburg, Pennsylvania, 17011, United States

Location

Soltero Cardiovascular Research Center

Dallas, Texas, 75226, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Metabolic Syndrome; Non-alcoholic Fatty Liver Disease; Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Fatty Liver; Liver Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study is a prospective, single-arm, multi-center, non-randomized trial

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 26, 2020
• Study Start: July 28, 2020
• Primary Completion: March 2, 2022
• Study Completion: December 19, 2022
• Last Updated: March 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)